A high-performance thin-layer chromatography densitometric method for the separation of isomeric ceftriaxone in powder for injection formulation.

Autor: Mwamwitwa KW; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65545, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.; Tanzania Medicines and Medical Devices Authority, P. O. Box 1253, Dodoma, Tanzania. ki313ssa@yahoo.com., Nyamweru B; Tanzania Medicines and Medical Devices Authority, P. O. Box 1253, Dodoma, Tanzania., Iwodyah MA; Tanzania Medicines and Medical Devices Authority, P. O. Box 1253, Dodoma, Tanzania., Sambu G; Tanzania Medicines and Medical Devices Authority, P. O. Box 1253, Dodoma, Tanzania., Nyondo GG; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65545, Dar es Salaam, Tanzania., Yondu E; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65545, Dar es Salaam, Tanzania., Fimbo AM; Tanzania Medicines and Medical Devices Authority, P. O. Box 1253, Dodoma, Tanzania., Manyanga V; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65545, Dar es Salaam, Tanzania., Sabiiti W; School of Medicine, University of St. Andrews, KY16 9TF, Fife, Scotland, UK., Shewiyo DH; Tanzania Medicines and Medical Devices Authority, P. O. Box 1253, Dodoma, Tanzania., Shearer MC; School of Medicine, University of St. Andrews, KY16 9TF, Fife, Scotland, UK., Smith AD; School of Chemistry, University of St. Andrews, KY16 9ST, Fife, Scotland, UK., Kaale EA; Pharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65545, Dar es Salaam, Tanzania.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2024 Nov 01; Vol. 14 (1), pp. 26308. Date of Electronic Publication: 2024 Nov 01.
DOI: 10.1038/s41598-024-77334-5
Abstrakt: The aim of this study was to develop and validate a High-Performance Thin Layer Chromatographic (HPTLC) method for simultaneous determination of ceftriaxone and ceftriaxone e-isomer in powder for injection formulation. Ceftriaxone sodium injection is an antibiotic that used globally. It has Z/E geometrical conformation, in which ceftriaxone sodium and 3 ene-isomer have Z- conformation while (E)-isomer has E- conformation and the potential toxicity of ceftriaxone (E)-isomer has been reported. Thus, to safeguard the public health, a simple and easy to use, rapid and reliable method was developed for qualitative and quantitative determination of ceftriaxone sodium and its (E)-isomer. Samples were applied on HPTLC glass plates precoated with silica gel 60F254 by using Linomat semi-auto sampler. Separation was carried out using acetone, triethyl amine, water, chloroform and ethyl acetate as a mobile phase in different ratios. The R f values of separated compounds were 0.51 ± 0.01 and 0.62 ± 0.01 for ceftriaxone sodium and ceftriaxone (E)-isomer respectively. The method was validated by studying Specificity, Linearity, Accuracy, Precision, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ) and Solution stability. The developed method was successfully, sensitive, simple, precise, accurate, robust and applicable for the simultaneous determination of ceftriaxone sodium and ceftriaxone (E)-isomer in powder for injection formulation.
(© 2024. The Author(s).)
Databáze: MEDLINE
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